Director/Sr. Director, Manufacturing

Beam Therapeutics•Durham, NC

17d•$250,000 - $310,000•Onsite

About The Position

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases. Position Overview: Beam is looking for a highly energetic Director / Senior Director, Manufacturing, to lead our internal manufacturing team. The Director / Senior Director, Manufacturing will be responsible for teams manufacturing multiple modalities, including mRNA, Lipid Nanoparticles, and Autologous Cell Therapy, for clinical and commercial supply. As a key member of the North Carolina Site Leadership Team, the individual will develop and implement operational strategies to build a nimble, flexible, efficient operation and ensure safe and reliable supply. The ideal candidate will be a seasoned leader with a demonstrated track record of building high performing teams. They will also possess the ability to interface successfully with multidisciplinary teams and build strong cross-functional relationships.

Requirements

BS, MS a plus, in Life Sciences or Engineering with minimum of 15 years of relevant experience.
Proven experience as a direct manager of people and as a leader in clinical and commercial cGMP manufacturing operations; experience leading cell/gene therapy manufacturing operations preferred.
Demonstrated deep technical knowledge of facility design considerations, process strategies, technology transfer, and manufacturing operations in a biotech/pharmaceutical environment.
Strong background in drug development and regulatory requirements.
Outstanding written and verbal written communication skills, with the ability to convey strategies and results to a diverse audience.
Demonstrated business acumen, including long range planning and budget management.
Dynamic interpersonal skills and the ability to manage through influence.
Ability to juggle multiple projects and priorities and adapt quickly to changing circumstances.
High degree of customer focus (internal/external) and demonstrated collaboration in a team environment.
Results oriented with the ability to demonstrate resiliency, ownership and drive.
Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA.
Travel for in-person interactions with cross-functional stakeholders.
This is an on-site position.

Responsibilities

Cultivate Beam’s culture and our values-driven organization focused on people.
Define and implement the mission, vision, and strategy for Beam internal cGMP Manufacturing, supporting both clinical and commercial operations.
Ensure safety, compliance, efficiency, and sustainability throughout cGMP operations.
Lead and coordinate resources to ensure quality standards are met and products are delivered on time and within budget.
Champion development of a learning culture that embraces innovation and continuous improvement.
Prepare and maintain departmental budget and workforce model.
Support establishment of long range and business continuity plans.
Develop and implement metrics/KPIs to monitor operational health, inform strategic decisions, and present materials at management reviews.
Build collaborative and empowered teams that put patients first.
Recruit, retain, and develop high-performing and diverse teams.
Represent department during audits and regulatory inspections.
Establish and maintain strong relationships at the site and cross-functionally.
Assures alignment of internal manufacturing schedules with product supply forecasts and program timelines.
Develops and maintains detailed manufacturing project plans, defines risks, and establishes contingency plans to ensure projects are delivered on time, within budget, and adhere to high quality standards.
Support facility and equipment design and qualification for ability to meet process and regulatory expectations.
Contributes to development and implementation of manufacturing documents (batch records, procedures, and technical reports).
Lead and/or assist with manufacturing deviation investigations and change controls.
Supports tech transfer and process scale-up in partnership with Process Development and Manufacturing Science & Technology.
Must be willing to have a flexible schedule to support a multi-shift operation that covers nights and weekends as needed.